National Law Review14d
A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule
Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with ...
GlobalData on MSN4mon
FDA LDT litigation could be ‘train wreck in the courts’
Litigation against the FDA's Final Rule on lab-developed tests (LDTs) is causing uncertainty to rise as the US regulator gears up for a legal clash with the lab industry. Since the FDA revealed ...
MedTech Dive15d
CAP urges HHS to revoke lab developed test rule, citing Trump order
The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for ...
pharmaphorum3d
Final FDA rule on LDTs creates a paradigm shift for laboratory manufacturers and partners, announces Avalere
2024 –The Food and Drug Administration’s (FDA) final rule has reclassified laboratory developed tests (LDTs) as medical devices, according to Avalere. The rule leads to a paradigm shift that ...
BioWorld16d
Loper Bright no free pass where FDA’s LDT rule is concerned
The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.
Watch live: Trump’s pick to lead FDA faces Senate confirmation hearing
Marty Makary, President Trump’s pick to lead the Food and Drug Administration (FDA), will testify before the Senate Health, ...
BioWorld16d
FDA’s LDT rule, CDS guidance combine to complicate regulatory life
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s ...
Hosted on MSN10mon
Tens of thousands of medical tests to now fall under federal oversight
But LDTs have grown in use over the years, as have concerns over their lack of regulatory oversight. Common LDTs today include tests for COVID-19, blood level tests and tests for drug abuse. While ...
pharmaphorum16d
Medical start-ups must address the evolving risks of the FDA's final rule (or get left behind)
An example of these ongoing threats recently materialised in the FDA’s final rule on laboratory-developed tests (LDTs). This recent change, which will be phased out in four years, categorises ...
JD Supra15d
A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule
We discussed the details of the LDT Final Rule in a previous Insight, explaining that as of the May 6, 2025 Phase 1 deadline FDA will expect all laboratories that manufacture LDTs to comply with ...